Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS

Sponsor
The Cleveland Clinic
Study ID
NCT07442747
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise — BEHAVIORAL
    Participants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.

Study Details

This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.

Key Dates

First listed
Mar 2, 2026
Start date
May 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Forced Exercise (FE)
    Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolutions per minute, while the participant continues to actively pedal. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own.
  • Experimental: Voluntary Exercise (VE)
    Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency.

Primary Outcome Measure

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) [ Time Frame: Baseline to EOT and Baseline to EOT+4 weeks ]

Central Contacts

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